NCT02438670

Brief Summary

The goal of this proposed study is to compare use of a PID (Proportional-Integral-Derivative) controller versus an MPC (Model Predictive Control) controller algorithm in an artificial pancreas system, all other components and study design being equal. The study design, power calculation and endpoints were developed based on the results of an initial feasibility study (ClinicalTrials.gov Identifier: NCT01987206) that has already been completed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

July 22, 2016

Status Verified

July 1, 2016

Enrollment Period

4 months

First QC Date

May 6, 2015

Last Update Submit

July 20, 2016

Conditions

Type 1 Diabetes Mellitus

Keywords

Artificial PancreasType 1 DiabetesMPCPID

Outcome Measures

Primary Outcomes (1)

  • Time spent in safe blood glucose range

    The percentage of time spent in safe blood glucose range of 70-180 mg/dl, comparing MPC, PID and the 24-hour period of Open-Loop Care just prior to each study session. More time spent inside the desired range will be considered successful.

    27.5-hours

Secondary Outcomes (1)

  • Glucose level extremes and need for outside intervention

    27.5-hours

Study Arms (3)

Open-Loop Care

NO INTERVENTION

The subjects Open-Loop Care for the 24-hour period prior to each study sessions assessed for time in the target range 70-180 mg/dL, and frequency of hypoglycemia and hyperglycemia as assessed by CGM.

PID algorithm with HMS

EXPERIMENTAL

Subjects will be treated with closed-loop care for 27.5h using a proportional-integral-derivative (PID) control algorithm, incorporating a personalized model of glucose-insulin dynamics. The health monitoring system (HMS) predicts impending hypoglycemia, and will be used in both experimental arms as an important safety feature of the device.

Device: PID control algorithm

MPC algorithm with HMS

EXPERIMENTAL

Subjects will be treated with closed-loop care for 27.5h using a model predictive control (MPC) control algorithm with HMS, using the identical model as in the first experimental arm. The health monitoring system (HMS) predicts impending hypoglycemia, and will be used in both experimental arms as an important safety feature of the device.

Device: MPC control algorithm

Interventions

PID control algorithmDEVICE
PID algorithm with HMS
MPC control algorithmDEVICE
MPC algorithm with HMS

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 6 months with commercially available rapid acting insulin.
  • The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
  • Age 21 to 65 years
  • For females, not currently known to be pregnant or nursing
  • HbA1c between 5 to 10%, as measured with DCA2000 or equivalent device
  • Willing to perform the calibration of the study CGMs using a fingerstick only and willing to follow instructions for insulin pump and CGM wear.
  • Willing to use the study CGM and study insulin pump during closed-loop.
  • Able to and agrees to avoid the following medication starting 24 hours before sensor wear through completion of the close loop study visit: acetaminophen, prednisone, and pseudoephedrine.
  • An understanding of and willingness to follow the protocol and sign the informed consent.

You may not qualify if:

  • Exhibit hypoglycemia unawareness.
  • Indications of cardiac arrhythmia.
  • Pregnancy (as determined by a positive blood pregnancy test performed in females of childbearing capacity during screening visit and urine test at time of admission for in-patient visit) or nursing mother.
  • Diabetic ketoacidosis in the past 6 months prior to enrollment requiring emergency room visit or hospitalization
  • Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
  • Current treatment for a seizure disorder; Subjects with a history of seizures may be included in the study if they receive written clearance from their neurologist
  • Active infection
  • A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as cognitive deficit.
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects not able to read or write.
  • Coronary artery disease or heart failure.
  • Subjects with a history of coronary artery disease may be included in the study if they receive written clearance from their cardiologist
  • Presence of a known adrenal disorder
  • Active gastroparesis
  • If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study
  • Uncontrolled thyroid disease; Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William Sansum Diabetes Center

Santa Barbara, California, 93105, United States

Location

Related Publications (1)

  • Pinsker JE, Lee JB, Dassau E, Seborg DE, Bradley PK, Gondhalekar R, Bevier WC, Huyett L, Zisser HC, Doyle FJ 3rd. Randomized Crossover Comparison of Personalized MPC and PID Control Algorithms for the Artificial Pancreas. Diabetes Care. 2016 Jul;39(7):1135-42. doi: 10.2337/dc15-2344. Epub 2016 Jun 11.

    PMID: 27289127RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jordan E Pinsker, MD

    Sansum Diabetes Research Institute

    PRINCIPAL INVESTIGATOR

  • Eyal Dassau, PhD

    University of California, Santa Barbara

    PRINCIPAL INVESTIGATOR

  • Francis J Doyle III, PhD

    University of California, Santa Barbara

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2015

First Posted

May 8, 2015

Study Start

May 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

July 22, 2016

Record last verified: 2016-07

Locations

US(1)